“Below are the 35 drugs we could find that have been recalled from the US market since the 1970s, some that had been in use since the 1930s. A sample of advertisements for only some of the drugs are included because there is a scarcity of ads for withdrawn drugs online due to manufacturers removing ads for withdrawn drugs as part of the agreement to no longer market the drugs.

According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.” The FDA also takes into account the number of people taking a drug being considered for removal so as to not harm those patients.”

Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.

2. Baycol (Cerivastatin)

on the market for 3 YEARS

Use: Cholesterol reduction Manufacturer: Bayer A.G.

1998 to Aug. 2001

Cause for recall:

rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid)

Cause for recall:
clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning

Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.

DES prescription drug ad
Barbara Hammes and Cynthia Laitman, “Pharmaceutical Company Advertisement for DES by the Grant Chemical Company, Brooklyn, NY, Printed in the American Journal of Obstetrics & Gynecology in 1957,” Journal of Midwifery and Women’s Health, www.medscape.com, 2003

Duract was labeled for maximum use of 10 days but patients often received/took more than 10 days worth of pills; all cases of death and liver damage involved patients taking pills for longer than 10 days.

Levamisole is still used to treat animals with worm infestations in the US. It is also being found in street cocaine as an adulterant to increase euphoric qualities.

10. Hismanal (Astemizole)

on the market for 11 YEARS

Use: Antipsychotic

Manufacturer: Janssen Pharmaceutica

1988 to Aug. 13, 1999

Cause for recall:

slowed potassium channels in the heart that could cause torsade de pointes (TdP; a heart condition marked by a rotation of the heart’s electrical axis) or long QT syndrome (LQTS; prolonged QT intervals)

11. Lotronex (Alosetron)

on the market for 0.8 YEAR

Use: Irritable bowel syndrome (IBS) in women

Manufacturer: Prometheus Laboratories, Inc.

Feb. 9, 2000 to Nov. 28, 2000

Cause for recall:

49 cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine)

Lotronex was reintroduced to the US market in 2002 with restricted indication.

FDA reviewer Dr. David Graham listed Meridia with Crestor, Accutane, Bextra, and Serevent as drugs whose sales should be limited or stopped because of their danger to consumers in Sep. 30, 2004 testimony before a Senate committee, calling the drugs “another Vioxx.”

13. Merital & Alival (Nomifensine)

on the market for 3 YEARS

Use: Antidepressant

Manufacturer: Hoechst AG (now Sanofi-Aventis)

1982 to 1985

Cause for recall:
haemolytic anemia; some deaths due to immunohemolytic anemia

14. Micturin (Terodiline)

on the market for 2 YEARS

Use: Bladder incontinence

Manufacturer: Forest Labs

Aug. 1989 to Sep. 13, 1991

Cause for recall:
QT prolongation and potential for cardiotoxicity

15. Mylotarg (Gemtuzumab Ozogamicin)

on the market for 10 YEARS

Use: Acute myeloid leukemia (AML, a bone marrow cancer)

Manufacturer: Wyeth

May 2000 to June 21, 2010

Cause for recall:
increased risk of death and veno-occlusive disease (obstruction of veins)

Cause for recall:
high levels of palladone could slow or stop breathing, or cause coma or death; combining the drug with alcohol use could lead to rapid release of hydromorphone, in turn leading to potentially fatally high levels of drugs in the system

18. Permax (Pergolide)

on the market for 19 YEARS

Use: Parkinson’s disease

Manufacturer: Valeant

1988 to Mar. 29, 2007

Cause for recall:
valve regurgitation (a condition that causes the valves to not close tightly, which allows blood to flow backward over the valve) in the mitral, tricuspid, and aortic heart valves, which can result in shortness of breath, fatigue, and heart palpitations

Permax is still available in the U.S. for veterinary use, specifically for pituitary pars intermedia hyperplasia or equine Cushing’s Syndrome (ECS) in horses.

Pondimin is better known as “Fen-Phen” when prescribed with Phentermine.

20. Posicor (Mibefradil)

on the market for 1 YEAR

Use: Calcium channel blocker (used to treat hypertension)

Manufacturer: Roche Laboratories

June 1997 to June 1998

Cause for recall:
fatal interactions with at least 25 other drugs (ex: common antibiotics, antihistamines, and cancer drugs) including astemizole, cisapride, terfenadine, lovastatin, and simvastatin

Posicor was found by the FDA to offer no significant benefit over other anti-hypertensive or antianginal drugs, which made the risks of drug interactions “unreasonable.” Patients immediately switching from Posicor to another calcium channel blocker were at increased risk of going into shock within 12 hours of the drug switch.

Cause for recall:
more than 270 cases of serious cardiac arrythmias (including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation) reported between July 1993 and May 1999, with 70 being deaths.

Propulsid is also banned in India (2011) and available for limited use in Europe. It is still available for use in animals in the US and Canada.

22. PTZ & Metrazol (Pentylenetetrazol)

on the market for 48 YEARS

Use: Convulsive therapy for schizophrenia and other psychiatric conditions Manufacturer: not known 1934 to 1982

Cause for recall:
uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients

Cause for recall:
progressive multifocal leukoencephalopathy (PML; a rare and usually fatal disease that causes inflammation or progressive damage of the white matter in multiple locations of the brain)

Anphar Labs (which developed the drug in France and sold rights to sell in US to SmithKline) sent a report to SmithKline in Apr. 1979 (translated in May 1979 to English from French) stating Selacryn damaged livers. On Dec. 13, 1984, SmithKline Beckman plead guilty to “14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage”

30. Seldane (Terfenadine)

on the market for 13 YEARS

Use: Antihistamine

Manufacturer: Hoechst Marion Roussel (now Sanofi-Aventis)

1985 to Feb. 1, 1998

Cause for recall:
life-threatening heart problems when taken in combination with other drugs (specifically erthromycin (an antibiotic) and ketoconazole (an antifungal)

Seldane was not considered an imminent threat. The FDA pulled Seldane from the market because Allegra and Allegra D were produced by the same company and were deemed safer by the FDA.

Barbara Hammes and Cynthia Laitman, “Pharmaceutical Company Advertisement for DES by the Grant Chemical Company, Brooklyn, NY, Printed in the American Journal of Obstetrics & Gynecology in 1957,” Journal of Midwifery and Women’s Health, www.medscape.com, 2003

David Healy, Let Them Eat Prozac: The Unhealthy Relationship between the Pharmaceutical Industry and Depression, 2004